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Levosimendan and Myocardial Protection

This study has been completed.
University College London Hospitals
Information provided by:
University of Roma La Sapienza Identifier:
First received: January 24, 2008
Last updated: February 6, 2008
Last verified: January 2008
The aim of this study is to investigate whether pharmacological pre-treatment with levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective myocardial revascularization under cardiopulmonary bypass.

Condition Intervention Phase
Myocardial Protection
Drug: levosimendan
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Levosimendan Pre-Treatment in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-Blind, Single Center, Prospective, Randomized, Placebo-Controlled Trial

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Length of ICU stay [ Time Frame: two weeks ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 3 weeks ]
  • Tracheal intubation time [ Time Frame: one week ]
  • Inotropic support over the first 7 days [ Time Frame: one week ]

Enrollment: 100
Study Start Date: January 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L Drug: levosimendan
24 μg/kg administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB
Experimental: P Drug: Placebo
an identical-appearing placebo prepared and labelled by the pharmacy was administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age ≥18 years
  • intention to perform first-time multi-vessel CABG

Exclusion Criteria:

  • unstable angina
  • valvular disease
  • diabetes mellitus treated with sulphonylurea drugs
  • renal failure
  • severe hepatic disease
  • severe chronic obstructive pulmonary disease
  • a history of prior CABG surgery
  • recent myocardial infarction (MI) within the previous month
  Contacts and Locations
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Please refer to this study by its identifier: NCT00610350

University of Rome "Sapienza"
Rome, Italy, 00155
Sponsors and Collaborators
University of Roma La Sapienza
University College London Hospitals
Principal Investigator: Vincenzo De Santis, M.D. University of Roma La Sapienza
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vincenzo De Santis, University of Rome "Sapienza" Identifier: NCT00610350     History of Changes
Other Study ID Numbers: LV 2003
Study First Received: January 24, 2008
Last Updated: February 6, 2008

Keywords provided by University of Roma La Sapienza:
cardiac surgery
myocardial function

Additional relevant MeSH terms:
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs processed this record on May 25, 2017